PET-imaging of Unruptured Intracranial Aneurysm Inflammation (PET-IA)

January 14, 2021 updated by: Jaakko Rinne, Turku University Hospital
The main purpose of this study is to determine if PET-imaging can be used to evaluate inflammation level of intracranial aneurysms, thus helping to evaluate the rupture risk of intracranial aneurysm.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study subjects are patients who are diagnosed with an unruptured saccular intracranial aneurysm and planned for elective surgical treatment of intracranial aneurysms. Prior the planned surgery, all study subjects will undergo PET-imaging of the brain with 18F-FDG- and 68Ga-DOTANOC-tracers targeting glucose metabolism and somatostatin receptors in inflammatory cells. After PET-imaging, samples for histopathological examination from the intracranial aneurysm sac will be collected during the surgery from every study subject. Blood samples are collected prior to aneurysm operation from the routine pre-operative laboratory tests. Cerebrospinal fluid samples are collected during the surgical procedure from the surgical site. From blood samples we will evaluate expression of 20 different circulating microRNAs (miRNA) and the level of tumor necrosis factor-1, interleukin 1 beta, vascular endothelial growth factor, and evaluate correlations between miRNA expression and SUVmax in PET-imaging and miRNA and aneurysm histological findings.

Correlation between inflammatory findings in histological studies and PET-imaging will be evaluated (correlation of SUVmax to aneurysm histological findings).

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20521
        • Recruiting
        • Turku University Hospital
        • Contact:
        • Principal Investigator:
          • Jaakko Rinne, MD, Prof.
        • Sub-Investigator:
          • Dan Laukka, MD
        • Sub-Investigator:
          • Antti Saraste, MD, Prof.
        • Sub-Investigator:
          • Melissa Rahi, MD, PhD
        • Sub-Investigator:
          • Juri Kivelev, MD, PhD
        • Sub-Investigator:
          • Johanna Kuhmonen, MD, PhD
        • Sub-Investigator:
          • Riitta Parkkola, MD, Prof
        • Sub-Investigator:
          • Maria Gardberg, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fusiform intracranial aneurysms
  • Following medications: Asetylsalisylic acid or non-steroidal anti-inflammatory drugs.
  • Patients who have contraindication for magnetic resonance imaging (Pace Makers, foreign ferromagnetic bodies or implants)
  • Patients who are allergic to contrast agents.
  • Pregnancy
  • Underage persons
  • Patients on somatostatin analogue medication or with known neuroendocrine tumor

Exclusion Criteria:

  • Patients who are diagnosed with unruptured intracranial aneurysm with MRI/MRA or DSA
  • Patients who are planned to undergo surgical treatment (ligation) of the intracranial aneurysm
  • Age ≥18 and <75 years.
  • Saccular intracranial aneurysm with maximum diameter ≥ 3 mm.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET-IA
68Ga-DOTANOC 18F-FDG
Radiation: PET imaging, 18F-FDG
PET-MRI with 18F-FDG
Radiation: PET imaging, 68Ga-DOTANOC
PET-CT with 68Ga-DOTANOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET-imaging of unruptured intracranial aneurysms
Time Frame: 1 month

Uptake of 18F-FDG or 68Ga-DOTANOC in intracranial arterial aneurysms as compared to contra-lateral normal vessel as SUVmax or TBR.

Correlation of uptake of 18F-FDG or 68Ga-DOTANOC (SUVmax or TBR) to aneurysm histological findings (CD45, CD3, CD5, CD20, CD138 and CD68, SSTR2, SSTR3 and SSTR5)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for intracranial aneurysm inflammation
Time Frame: 1 month
Uptake of 18F-FDG or 68Ga-DOTANOC and histological findings correlation to aneurysm size and shape, smoking, hypertension, location of aneurysm.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

University of Turku

Investigators

  • Principal Investigator: Jaakko Rinne, MD, Prof., Turku University Hospital, Neurocenter, Department of Neurosurgery, Division of Clinical Neurosciences, University Of Turku
  • Study Director: Antti Saraste, MD, Prof., Turku University Hospital, Heart Centre, University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T225/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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